Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019627
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIPRIVAN PROPOFOL 10MG/ML INJECTABLE;INJECTION Discontinued None No No
DIPRIVAN PROPOFOL 10MG/ML INJECTABLE;INJECTION Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/02/1989 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/27/2017 SUPPL-66 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019627s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019627Orig1s066ltr.pdf
04/17/2015 SUPPL-64 Manufacturing (CMC)

Label is not available on this site.

06/08/2014 SUPPL-62 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019627s062lbl.pdf
07/09/2013 SUPPL-60 Manufacturing (CMC) Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019627s60lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019627Orig1s060ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/019627Orig1s060.pdf
05/05/2014 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

04/14/2008 SUPPL-46 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019627s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019627s046ltr.pdf
02/08/2007 SUPPL-45 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019627s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019627s045ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/019627_S045_DIPRIVAN.pdf
09/03/2002 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

10/27/2000 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

02/07/2000 SUPPL-37 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/07/1999 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

02/23/2001 SUPPL-35 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19627S35LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19627S35LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019627_S035_DiprivanTOC.cfm
04/29/1999 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

02/04/1999 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

09/29/1998 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

04/29/1999 SUPPL-31 Labeling

Label is not available on this site.

09/11/1997 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

06/11/1996 SUPPL-27 Manufacturing (CMC)-Formulation Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019627_S027_Diprivan_APPROVAL_PACKAGE.pdf
07/31/1995 SUPPL-24 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/21/1995 SUPPL-23 Labeling

Label is not available on this site.

05/06/1994 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

02/24/1995 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/07/1994 SUPPL-19 Labeling

Label is not available on this site.

10/26/1993 SUPPL-18 Labeling

Label is not available on this site.

10/26/1993 SUPPL-17 Efficacy-New Indication

Label is not available on this site.

12/11/1992 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

02/25/1992 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

03/08/1993 SUPPL-10 Efficacy-New Indication

Label is not available on this site.

05/09/1994 SUPPL-8 Labeling

Label is not available on this site.

03/09/1993 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

01/18/1991 SUPPL-5 Labeling

Label is not available on this site.

01/18/1991 SUPPL-4 Labeling

Label is not available on this site.

01/18/1991 SUPPL-3 Labeling

Label is not available on this site.

12/31/1991 SUPPL-2 Efficacy-New Indication Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019627_S002_Diprivan.pdf
01/18/1991 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/27/2017 SUPPL-66 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019627s066lbl.pdf
06/08/2014 SUPPL-62 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019627s062lbl.pdf
07/09/2013 SUPPL-60 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019627s60lbl.pdf
04/14/2008 SUPPL-46 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019627s046lbl.pdf
02/08/2007 SUPPL-45 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019627s045lbl.pdf
02/23/2001 SUPPL-35 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19627S35LBL.pdf

DIPRIVAN

INJECTABLE;INJECTION; 10MG/ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIPRIVAN PROPOFOL 10MG/ML INJECTABLE;INJECTION Prescription Yes AB 019627 FRESENIUS KABI USA
PROPOFOL PROPOFOL 10MG/ML INJECTABLE;INJECTION Prescription No AB 205067 DR REDDYS
PROPOFOL PROPOFOL 10MG/ML INJECTABLE;INJECTION Prescription No AB 077908 HOSPIRA
PROPOFOL PROPOFOL 10MG/ML INJECTABLE;INJECTION Prescription No AB 075102 SAGENT PHARMS INC
PROPOFOL PROPOFOL 10MG/ML INJECTABLE;INJECTION Prescription No AB 205307 WATSON LABS INC

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